MAUDE Adverse Event Report: HALYARD - IRVINE ASKU; ELASTOMERIC PUMP

Model Number ASKU

Device Problems Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Respiratory Distress (2045)

Event Date 09/22/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: the device was reported as not available for return and analysis.The reporter was unable to provide a lot number; thus, the device history record (dhr) review cannot be conducted.Results: the information contained is from a potential legal claim served on halyard health.The complaint was opened so that a medical device report (mdr) can be filed with the us food and drug administration.No further investigation will be conducted.Conclusions: the device was not returned to halyard for evaluation, therefore we are unable to determine the cause for the reported event; however, the patient reports that as a result of his side effects alleged to be the development of fluid in his lungs.As this complaint was created from a threat of a lawsuit received by halyard health; no customer contact can be made at this time due to the threatened litigation.Information from this incident will be included in our product complaint and mdr trend reporting system.Device not returned for evaluation.

Event Description

Fill volume: asku, flow rate: asku, procedure: full left shoulder replacement, cathplace: neck.A patient sent a letter to the deputy general counsel in which he claimed to have experienced trouble breathing with the use of an on-q pump.The patient's symptoms dissipated once the infusion was stopped.The patient reported problems breathing as he was placed on the operating table.The breathing problems continued sporadically that day after surgery and into the next morning.The pump was discontinued and after one hour the symptoms dissipated.Medical personnel determined that the pump had partially paralyzed the patient's diaphragm and restricted proper breathing.The patient reports that as a result of the side effects the patient experienced fluid on his lungs and required extensive medical treatments for the following 4 days to clear his condition.The patient was discharged from the hospital on (b)(6) 2015.No further patient or procedure information was provided.

• Brand Name: ASKU
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-18; fraccionamiento rubio; tijuana, b.c. 22116 ; MX 22116
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5269094
• MDR Text Key: 32747219
• Report Number: 2026095-2015-00334
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention